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Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
 Last updated: April 09, 2018
 STATUS: Closed to accrual (not accepting new patients) (perClinicalTrials.gov/NCT02231749)


is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • clear-cell component
  • advanced and/or metastatic disease
  • no prior systemic therapy for RCC
  • overall health status has to be good (Karnofsky Performance Status of at least 70%)
  • tumour tissue [formalin-fixed paraffin-embedded (FFPE)] has to be available 


is the key question that this trial is attempting to answer?

This phase-III study seeks to clarify whether the new immunotherapies are superior
to one of the standard therapies for kidney cancer.
This particular study investigates the combination of the immune-checkpoint inhibitors
ipilimumab and nivolumab versus sunitinib in advanced renal cell carcinoma.


patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy that may be effective for kidney cancer. This trial will further support the research in kidney cancer and potentially help other patients with kidney cancer. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.


will the trial be open?

The study is closed to accrual – 1070 patients worldwide were expected to participate.


is the trial available?

The trial was available in 184 cancer centres worldwide in 28 countries.
For a complete list of trial locations, please download the following document:



What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Please note that patients in both groups will receive an active medication. No patient receives a placebo.

Patients in one group will be assigned nivolumab (OpdivoTM) in combination with ipilimumab (YervoyTM). Patients in the other group will be treated with sunitinib (SutentTM), which is an approved treatment for RCC.

  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4
  • sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor, already approved for the treatment of metastatic RCC
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1) The combination of nivolumab and ipilimumab is given intravenously every 3 weeks for 4 doses.

2) After that patients will receive nivolumab intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the end of the study.

3) Sunitinib is taken by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.


do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.


with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.


your experience 

You want to share your experience on this trial?
Send us an e-mail to: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.
Note that your experience would be helpful for other patients and patient organisations.


of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
Back to clinical trials overview: How can I find an IO clinical trial for my cancer?